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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA X 35 ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA X 35 ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-05503-UPM1
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device investigation is pending. Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the user had trouble feeding the catheter. An attempt was made to feed it without the blue piece, the thread assists, and it was still difficult to pass. As the catheter was pulled back some foreign material came out. The results of an x-ray performed on the patient was negative.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the epidural catheter and needle with no relevant findings. The customer reported the catheter was difficult to thread through the epidural needle. The customer returned one snaplock adapter, one epidural catheter, and lidstock. No needle was returned. The components were received connected together. The returned components were visually examined with and without magnification. The snaplock adapter appears typical with no defects or anomalies observed. Visual examination of the returned epidural catheter revealed that the catheter appears used. Biological material can be seen between the catheter coils and adhesive residue is present on the catheter body exterior. No other defects or anomalies were observed. The customer also returned several photos which displays what allegedly was removed from the needle causing it to be blocked (b)(4). The outer diameter (od) of the returned catheter measured 1. 06mm (caliper c05155) which is within the specification of a maximum of 1. 115mm per graphic kz-05400-002; rev 9. An attempt to thread the returned epidural catheter was made. The distal end of the catheter would thread through a lab inventory 17ga needle with no resistance met. A drag test was performed per pip-013 using the returned catheter, a lab inventory needle and weight (c05406). The catheter passed the drag test with the lab inventory needle. Specifications per graphic kz-05400-002; rev. 9 was reviewed as a part of this complaint investigation. A review of design change history for part number an-02017-001b was performed as a part of this investigation. No design changes have been made to this part in the past two years that would have led to this complaint. The reported complaint of the catheter being difficult threading through the needle could not be confirmed based on the sample received. The customer returned a catheter but no needle was returned. The returned epidural catheter could be thread through a 17ga lab inventory needle with no resistance met. The returned catheter also passed a functional drag test, and the returned catheter od was found to be within specification. The customer also returned several photos that show material allegedly removed from the needle causing the blockage. A device history record review was performed on the epidural catheter and needle with no relevant findings. However, based on the photos provided by the customer, a nonconformance has been initiated to further investigate this issue.
 
Event Description
It was reported that the user had trouble feeding the catheter. An attempt was made to feed it without the blue piece, the thread assists, and it was still difficult to pass. As the catheter was pulled back some foreign material came out. The results of an x-ray performed on the patient was negative.
 
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Brand NameEPIDURAL CATHETERIZATION KIT: 19 GA X 35
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7739888
MDR Text Key115777974
Report Number1036844-2018-00212
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberASK-05503-UPM1
Device Lot Number23F18A0331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

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